FDA 510(k) Application Details - K021132

Device Classification Name Media,Coupling,Ultrasound

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510(K) Number K021132
Device Name Media,Coupling,Ultrasound
Applicant THE LUDLOW COMPANY LP
TWO LUDLOW PARK DR.
CHICOPEE, MA 01022 US
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Contact M. BETH RICE
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Regulation Number 892.1570

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Classification Product Code MUI
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Date Received 04/09/2002
Decision Date 05/15/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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